European thumbs up for Abbvie leukaemia drug
pharmafile | December 8, 2016 | News story | Medical Communications, Sales and Marketing | AbbVie, Venclyxto
Abbvie has confirmed its Venclyxto (venetoclax) has been granted marketing authorisation by the European Commission (EC) as a monotherapy for the treatment of chronic lymphocytic leukaemia (CLL) in adult patients.
Venclyxto is an oral, once-daily treatment that works by selectively inhibiting the function of the BCL-2 protein, restoring the body’s ability to trigger cancer cell self-destruction. It is recommended for use in patients in the absence of 17p deletion or TP53 mutation for whom both chemo-immunotherapy and a B-cell receptor (BCR) inhibitor has failed or not proved effective. It is also indicated in the presence of 17p deletion or TP53 mutation who are either unsuitable for or have failed a BCR inhibitor.
The decision was based on data generated from a Phase 2 study of 64 CLL patients who relapsed or were refractory to BCR inhibitors. The trial found that Venclyxto achieved an objective response rate (ORR) of 67%, with 25% of patients achieving minimal residual disease (MRD) negativity in the peripheral blood in one arm; in the second, studying 107 relapsed/refractory CLL patients with 17p deletion, ORR was 79%, with 7% in complete remission.
Professor Peter Hillmen, consultant haematologist at Leeds Teaching Hospitals NHS Trust and coordinating investigator of the Venclyxto studies in the UK commented: “Venetoclax represents an important new option to offer eligible patients with CLL who have a very poor outcome with conventional therapies. Studies have shown that clinically significant numbers of patients respond to the treatment, with a number of these achieving complete responses.
“For clinicians, it has been meaningful to observe that some patients are achieving a deeper remission where minimal disease is not detectable on a molecular level, rarely seen in pre-treated patients. These types of clinical advances are bringing us closer than ever to successfully treating these types of cancers.”
CLL causes an accumulation of abnormal and immature lymphocytes in patients which renders them less able to defend from attacks on the immune system, with symptoms including swollen lymph glands, weight loss, fever and severe fatigue.
Abbvie UK’s medical director Alice Butler also said of the news:“AbbVie is making significant investment in studying ways to block BCL-2 activity in cancer and with this licence we are very pleased by the opportunity to bring venetoclax to eligible UK patients who have had limited options to date.”.
Affecting almost 3,500 people in the UK, CLL is the most common form of leukaemia in adults and commonly recurs despite treatment, with survival ranging from two or three years to just three months dependant on personal circumstances.
Matt Fellows
Related Content
Genmab to submit FDA application for lymphoma therapy
Global biotechnology company Genmab plans to submit a supplemental Biologics License Application (sBLA) to the …
The National Institute for Health and Care Excellence announce technology appraisal guidance recommending risankizumab for adult patients with moderate to severe ulcerative colitis
The National Institute for Health and Care Excellence (NICE) have recommended adult patients in England …
Abbvie acquires Cerevel Therapeutics
Abbvie has announced the acquisition of Cerevel Therapeutics, strengthening its neuroscience pipeline. Cerevel has multiple …
